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Auto Disabled Syringe, 0.5ml, w/permanently att. needle,sterile,single use - 1001987

Product ID: ITM-1001987
generic
Product Description:
Auto Disabled Syringe (0.5ml) preaffixed permanently to a needle with a protective cap. For accurate administration of low volume injectables.
Sterile, single use, disposable.
Sterilization method: ethylene oxide of gamma radiation.
Non-toxic. Pyrogen free.
Safety Engineered Feature : The syringe has an auto-disable technology feature that passively activates upon starting administration of the prescribed injectable dose to prevent subsequent re-use of the syringe. Various mechanisms either standalone of in combination e.g. Auto Disposable (AD), Reusable Prevention (RUP), Sharp Injury Prevention (SIP), Retractable Needle (RTN) may be considered. Mandatory product compliance standards ISO 7886 and ISO 23908.Fixed volume. Primary package consists of an individual blister pack. Pre-sterilized.
Syringe:
Capacity: 0.5 ml.
Graduated scale on the barrel with 0.01 ml (minor) and 0.1 ml (major) increment lines.
Barrel sufficiently transparent to allow easy measurement of the volume contained in the syringe and detection of air bubbles.
The Luer nozzle shall be situated centrally.
Material: Medical grade plastic; Polyethylene (PE), polypropylene (PP), polystyrene (PS).

Needle:
Material: Needle - stainless steel. Base and protective cap - Medical grade plastic.
Normal and thin walled.
External diameter expressed in gauge and millimetres.
Length expressed preferably in millimetres.
Size: 27G (approx. 0.4 x 13mm)
Needle tip: regular bevel.
Silicone coated to facilitate insertion.
Internationally recognized colour code system allows easy identification of the hypodermic needle's external diameter.

Cap:
The cap protects the needle, and preserves the sterility of the needle.
Material: polypropylene (PP).

Supplied with:
Manufacturer’s instructions for use may be printed onto the primary packaging of provided on a separate insert.
Languages: English, Spanish and French.

Accessories / Spare Parts / Consumables (available but not supplied):
N/A

Intended use:
For intramuscular (IM) injection: children, newborns.
To administer low volume injectables, such as Vitamin K 2mg/0.2 ml solution for newborns (0.040 to 0.100 ml volumes).
This syringe type is typically used for insulin of tuberculin injections.
Safety process: The needle is for single use only. Use aseptic techniques.

Packaging and Labelling:
Primary packaging: Unit of use.
One (1) syringe packed in an individual sterilised peel pack made of paper and/of plastic.
Secondary packaging: Protected unit.
One (1) box of hundred (100) blister packed syringes.
Primary package label includes:
Device intity and intended purpose.
Manufacturer's product code of reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD and EXP.
Any residual device risks, warnings, limitations of contraindications.
Symbols used according ISO 15223.
CE mark.
The word "sterile" (of equivalent harmonised symbol).
Sterilisation method (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the package integrity before use", of similar warning.
The words "dispose after use", if space allows.
Secondary package label includes the number of units.



Pack SizeAvg. Price
Pack of 100$5.28